RecruitingNot ApplicableNCT06249906

Efficacy of Bioceramic Materials for Bone Defects Repair

Clinical Study of Bioceramic Materials in Bone Defect Repair


Sponsor

Nanjing First Hospital, Nanjing Medical University

Enrollment

10 participants

Start Date

Feb 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to demonstrate the effect of bioceramic implants on the repair of human bone defects, and to explore the application of bioceramic materials in bone defects, bone implantation, and bone fusion. The surface microstructure of β-tricalcium phosphate bioceramic implants can be effectively controlled to guide the regeneration of bones, promote the restoration of bones, accelerate the speed of recovery, and improve bone quality, which is of great clinical and social significance.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

  • Patients who voluntarily take the test and sign the informed consent form;
  • Patients aged 18-65 years old with no history of allergies;
  • Patients able to communicate well with the investigator and follow the requirements of the entire trial.

Exclusion Criteria6

  • Patients who refuse to sign the informed consent form to participate in the trial;
  • Patients who are not in the age range of 18 to 65 years;
  • Patients with diseases unsuitbale for the trial: history of allergies, severe cardiopulmonary disease, coagulation dysfunction, Alzheimer's disease, cerebral atrophy, acute phase or sequelae of cerebrovascular disease, cognitive impairment;
  • Patients in the acute phase of local or systemic bacterial infections;
  • Patients who cannot cooperate with the operation and evaluate the effect;
  • Other conditions that are considered inappropriate by the investigator to participate in the study.

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Interventions

DEVICECommercial bone implant product Group

Commercial bone implant product Group with a smooth surface (without particular microstructures).

DEVICEMirco-structured Bioceramic Group

β-tri-Calcium phosphate with microstructures such as grooves, patterns and so on.


Locations(1)

Nanjing First Hospital

Nanjing, Jiangsu, China

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NCT06249906


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